Analytical Lead, Targeted LNP (tLNP) CMC

Job title: Analytical Lead, Targeted LNP (tLNP) CMC

About the Role The Analytical Lead within AbbVie's Targeted LNP (tLNP) CMC organization will be a cross-functional scientific leader responsible for developing and applying state-of-the-art analytical methods to characterize tLNP medicines, support process understanding, and enable product development. You will independently devise innovative approaches in electrophoresis and chromatography, lead development teams, and coordinate testing with internal and external manufacturing and testing partners.

What You'll Do

• Function as a principal research scientist, generating original technical ideas and development strategies.
• Represent the tLNP Analytical Research and Development Group as Analytical Lead on CMC development teams and serve as a subject matter expert on cross-functional project teams.
• Supervise a team of one or more scientists and be accountable for their performance and development.
• Develop, optimize, qualify/validate, and transfer fit-for-purpose QC release and stability methods.
• Provide technical support and oversight for QC testing conducted at internal and external GMP laboratories.
• Plan, author, and review regulatory submission documents, responses to health authority queries, technical reports, lab data, stability protocols/reports, and method qualification/validation protocols.
• Generate new scientific proposals and lead those efforts; anticipate regulatory advances or competitive threats and respond with new strategies.
• Demonstrate scientific initiative and creativity in research or development activities; maintain a high level of productivity.
• Embrace diverse ideas, nurture innovation, and manage innovation toward impactful deployment.
• Uphold AbbVie safety, quality and regulatory policies and government regulations and ensure data integrity in all work.

What We're Looking For

• 12 years (MS) or 6 years (PhD) of related industry experience.
• Demonstrated expertise in analytical method development for biologics, with hands-on experience in capillary electrophoresis and HPLC.
• Experience supporting biologics CMC development, QC method qualification/validation, and method transfer.
• Proven ability to interpret complex data, solve technical problems, and propose innovative scientific solutions.
• Experience contributing to regulatory submissions, including quality and characterization sections, and responding to health authority questions.
• Ability to supervise and mentor other scientists; coordinate testing work at internal and external laboratories.
• Working knowledge of data integrity and GxP compliance.
• Strong presentation and communication skills; ability to explain data, controls, and risk assessments to technical and non-technical audiences.
• Creative, out-of-the-box thinking to solve difficult problems; self-motivated, detail-oriented, and able to work in a fast-paced team environment.

Nice to Have

• Experience with mRNA-LNP or lipid nanoparticle analytics would be favorable.

Compensation & Benefits

• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) to eligible employees.
• This job is eligible to participate in our long-term incentive programs.